510(k) K760674
- Device
- SYN-O-SCOPE NASAL INHALER
- Applicant
- MCDONALD AND ASSOC., INC.
- 510(k) number
- K760674
- Product code
- KCO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-03-10
- Date received
- 1976-09-16
- Regulation
- 874.5220
- Classification name
- Nasal Spray, Ent Delivery
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3015789003
- 2248903
- 3015219237
- 3022833366
- 3008174904
- 1210513
- 3013000203
- 3038197210
- 3033571062
- 3008808560
- 3030726486
- 3006542993
- 1450662
- 3007225047
- 9611004
- 3010400793
- 1526711
- 3016170587
- 9615834
- 3025604927
- 3003002183
- 3012896103
- 1649184
- 3021393557
- 3011015568
- 3011919098
- 3021011196
- 3023229437
- 8040278
- 1225580
- 3010200299
- 3009302820
- 3003887292
- 3022764539
- 2522811
- 3030992394
- 3012314549
- 3004155943
- 3029768211
- 1424263
- 3023876581
- 3043338342
- 3043149283
- 9680518
- 9611283
- 3012421607
- 3007644779
- 1320681
- 1530671
- 3003617485
- 3025583702
- 3042277215
- 1720929
- 2032098
- 3006542501
- 1831301
- 3043648109
- 3011418975
- 3010683450
- 3005630901
- 3008177911
- 3010287621
- 3008080893
- 8010692
- 3015745029
- 3016181636
- 3043106343
- 3043585719
- 2954718
- 3016872092
- 3009529084
- 3016585381
- 3009595561
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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